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17,754 catalysts · 4,645 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,317 device pma
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17,754 catalysts · 4,645 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,317 device pma
Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Sponsor: ACER. Form: FOR SUSPENSION. Route: ORAL
Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: UMEDICA. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: GMQ. Advisory committee: Microbiology. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QXQ. Advisory committee: General Hospital. Type: Traditional
Product code: NBW. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: SGE. Advisory committee: Neurology. Type: Special
Product code: PZP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PLV. Advisory committee: Dental. Type: Traditional
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NPT. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MYL. Advisory committee: MI. Decision: APPR
Supplement type: Panel Track. Product code: MJO. Advisory committee: OR. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601; ANESTHESIA CIRCUIT - LF DYNJAA10261B; ANESTHESIA CIRCUIT 120EXP-LF DYNJAA10741A; ANESTHESIA CIRCUIT ADULT-LF DYNJAA0380A DYNJAA10641 DYNJAA10706B DYNJAA10851 DYNJAA10922B DYNJAA10971A DYNJAA11030A DYNJAA11087 DYNJAA11126; ANESTHESIA CIRCUIT-LF DYNJAA0309A DYNJAA0368A DYNJAA10368A DYNJAA10392 DYNJAA10430A DYNJAA10547A DYNJAA10639A DYNJAA10656A DYNJAA10685A DYNJAA10685B; CIRC 120" EXP 1 BV HMEF 3L GSL DYNJAA10920; EXPANDABLE CIRCUIT-LF DYNJAA11095; NM ANESTHESIA TURNOVER KIT DYNJAA0433; PROV HEALTH HEPA CIRC #2-LF DYNJAA0360; SPTMPX01IA CIRCUIT ADULT-LF DYNJAA10973A; — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Convenience Kit, BREAST HERNIA DYNJ909125G — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing